Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

A Phase 3 Study to Evaluate the Efficacy and Safety of JointStem in Treatment of Osteoarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03990805
Recruitment Status : Recruiting
First Posted : June 19, 2019
Last Update Posted : June 19, 2019
Sponsor:
Information provided by (Responsible Party):
R-Bio

Tracking Information
First Submitted Date  ICMJE June 13, 2019
First Posted Date  ICMJE June 19, 2019
Last Update Posted Date June 19, 2019
Actual Study Start Date  ICMJE June 11, 2019
Estimated Primary Completion Date June 3, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2019)
  • Change of Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) scores from baseline [ Time Frame: 12 weeks, 24 weeks ]
    Pain, stiffness, and physical function of the knee will be measured by the WOMAC score
    • Score range is
      1. 0-20 for Pain
      2. 0-8 for Stiffness
      3. 0-68 for Pysical Function
    • Higher scores on the WOMAC indicate wors pain, stiffness, and functional limitations
  • Change of Visual Analog Scale (VAS) scores from baseline [ Time Frame: 12 weeks, 24 weeks ]
    Pain of knee will be measured by the 100mm VAS -Score range is from 0-4mm(no pain) to 75-100mm(severe pain)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2019)
  • WOMAC 3 subscale score [ Time Frame: 12 weeks, 24 weeks ]
    Pain, stiffness, and physical function of the knee will be measured by the Western Ontario and McMaster Universities (WOMAC)
  • VAS score [ Time Frame: 12 weeks, 24 weeks ]
    Pain of knee will be measured by the 100mm Visual Analog Scale (VAS)
  • KOOS [ Time Frame: 12 weeks, 24 weeks ]
    Symptoms, pain and functionality of the knee joint will be evaluated via the Knee Injury and Osteoarthritis Outcome Score (KOOS) -Score range is from 0(extreme symptoms) to 100(no symptoms)
  • SF-36 [ Time Frame: 12 weeks, 24 weeks ]
    The SF(Short Form)-36 Health Survey is a 36-item, patient-reported survey of patient health.
  • IKDC [ Time Frame: 12weeks, 24 weeks ]
    Symptoms, sports activities, and function of the knee will be measured by the International Knee Documentation Committee (IKDC)
  • Measuring of Kellgren-Lawrence grade [ Time Frame: 12 weeks, 24 weeks ]
    Measuring of Kellgren-Lawrence grade through X-ray
  • Measuring of Femoro-tibial anatomical angle(FTA) [ Time Frame: 12 weeks, 24 weeks ]
    Measuring of FTA through X-ray
  • Measuring of Hip-Knee-Ankle angle(HKA) [ Time Frame: 12 weeks, 24 weeks ]
    Measureing of HKA through X-ray
  • Measuring of Joint Space Width [ Time Frame: 12 weeks, 24 weeks ]
    measuring Joint Space Width through X-ray
  • MRI scan [ Time Frame: 12 weeks, 24 weeks ]
    MRI perform to measure Modified WORMS (Whole-Organ Magnetic Resonance Imaging Score)
  • Use of rescue medication [ Time Frame: 12 weeks, 24 weeks ]
    Frequency and total amount of rescue medication administration will be measured.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 3 Study to Evaluate the Efficacy and Safety of JointStem in Treatment of Osteoarthritis
Official Title  ICMJE Multi-center, Randomized, Double-Blind, Placebo Controlled Phase 3 Clinical Trial to Evaluate Efficacy and Safty of Mesenchymal Stem Cells JointStem in Patients With Knee Osteoarthritis
Brief Summary The purpose of this study is to investigate the efficacy and safety of autologous Adipose Tissue derived Mesenchymal stem cells (JOINTSTEM®) in patient with severe Knee Osteoarthritis.
Detailed Description

JOINTSTEM is injectables for an OA treatment that uses autologous adipose-derived mesenchymal stem cells. As it does not use allogenic tissues and is cultured without additional genetic modification, it is classified as 'autologous cell therapy' and is completely free of immunologic rejection.

It primarily aims to improve joint function. The intra-articular injection of JOINTSTEM is expected to stimulate the regeneration of cartilage, and to innovatively improve joint function with cartilage regeneration.

The subjects of this therapy were patients with K&L grade 3 aged 20 or older.

This study is a double-blind, randomized, placebo controlled study with two arms to evaluate JOINTSTEM as a treatment for subjects with osteoarthritis. Following a 2-week screening period, approximately 260 patients will be randomly assigned into one of the following two arms in a 1:1 ratio (1 JointStem : 1 placebo control). After each patient completes 6-month visit (Visit 5) and the data management team confirms all data have no issue, the individual database will be locked and the blinding will be open for the statistical analysis.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Degenerative Arthritis
  • Knee Osteoarthritis
Intervention  ICMJE
  • Biological: JOINTSTEM
    JOINTSTEM Autologous Adipose Tissue derived MSCs 1x10^8cells/(saline), 1 time injection
    Other Name: Autologous Adipose Tissue derived MSCs
  • Drug: saline
    saline, 1 time injection
Study Arms  ICMJE
  • Experimental: JOINTSTEM
    Autologous Adipose Tissue derived MSCs
    Intervention: Biological: JOINTSTEM
  • Placebo Comparator: saline
    saline
    Intervention: Drug: saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 17, 2019)
260
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 30, 2020
Estimated Primary Completion Date June 3, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age 20 and older, male and female
  2. Patients must consent in writing to participate in the study by signing and dating an informed consent document
  3. Diagnosis of degenerative arthritis of class 1-3 by ACR(American College of Rheumatology Criteria) Global functional criteria
  4. Diagnosis of Kellgren and Lawrence grade 3 by radiographic criteria
  5. Patients suitable for one of three conditions of 'diagnostic criteria for osteoarthritis of knee' based on ACR guideline

    • clinical and inspectional opinion
    • clinical and radiographic opinion
    • clinical opinion
  6. Patients who has joint pain ≥ 50mm on 100mm VAS (Visual Analog Scale) at Screening
  7. Patient who has WOMAC score ≥ 1000 at Screening
  8. No improvement with persisting knee pain at least for 12 weeks (3 months) by nonoperational therapy before Screening

Exclusion Criteria:

  1. Patients who have pregnancy plans within this trial period or childbearing age patients who do not agree to maintain contraception status through appropriate contraception methods

    • Appropriate contraception method: Use of condom, contraceptive sponges, foam, diaphragm, intrauterine device etc.
    • Periodic abstinence(e.g. methods of predicting ovulation) and moderation are not considered as appropriate contraception method.
    • Not allowed to use hormonal contraceptives
    • Childbearing age female patients, exclude menopausal female (amenorrhea for more than 24 months after the last menstruation) or female who has no possibility of pregnency by surgical sterilization operation, can participate in this study only determined negative in pregnancy test
  2. Pregnant women or lactating mothers
  3. Patients with Body Mass Index (BMI) > 35
  4. Patients with positive human immunodeficiency (HIV), hepatitis B (HBV), hepatitis C (HCV), syphilis at screening indicative of current of pass infection
  5. Patients with other disease including

    • Septic arthritis, Rheumatoid or Inflammatory joint disease, Gout, Reccurent pseudogout, Paget disease, Articular fractures, Ochronosis, Acromegaly, Hemochromatosis, Wilson's disease,Osteochondromatosis, Hereditary disorder, Genetic disorder of collagen
  6. Patients who are diagnosed with malignant tumor in the past or present
  7. Patients who have clinically significant diseases including

    • Cardiac disorder (Myocardial infarction, Coronary artery bypass graft, Arrhythmia and other severe Cardiac disorder etc.)
    • Resistant hypertension (systolic blood pressure > 160mmHg or diastolic pressure > 100mmHg at Screening)
    • Kidney disease (Chronic renal failure, Glomerulonephritis etc.)
    • Liver disease (Hepatocirrhosis, Fatty liver, acute or chronic liver disease etc.)
    • Endocrinopathy (Thyroiditis, Diabetes insipidus, Cushing disease etc.)
  8. Patients who have significant lab abnormalities
  9. Patients who have severe pain in other areas that can affect the judgement of knee joint symptom
  10. Patients who underwent any arthroscopic surgery on the injection site within 6 months of the screening visit date, or scheduled to perform any surgery during the clinical trial period
  11. Patients who received any drug by intra-articular injection(hyaluronic acid or steroid etc.) for treatment within 6 months prior to Screening
  12. Patients who experienced as stem cell therapy or blood product injection(PRP, Prolo injection etc.)
  13. Patients who received treatment within 14 days prior to Screening including(But, patients who had wash-out-period can participate in this study)

    • Take medicines including composition of Glucosamine, Chondretin sulphate and Diacerhein etc.
    • Take phytotherapeutic agent or Chinese medicine for osteoarthritis
    • Take antiinflammatory analgesic drug, NSAIDs (prescription/nonprescription pharmaceuticals) etc. (Patients who have 3 days of wash-out-period after they took acetaminophen can participate in the study)
    • Take oral steroids
    • Physical therapy or Chinese medical treatment(cupping, acupuncture, moxibustion etc.)
  14. Patients with penicillin hypersensitivity reactions
  15. Patients with skin diseases or infections in the area of the injection site
  16. Patients who have abnormal flail over grade 2 flail knee test of anterior to posterior and varus/valgus lesion at physical examination
  17. Patients who have difficulty in taking MRI because of metal materials (cardiac pacemaker or clip of cerebral artery etc.) in their body or claustrophobia -but, patients with metal materials that are not affected by magnetic field can participate in this study
  18. Patients who have difficulty in liposuction or local anesthesia
  19. Patients who have alcohol, drug abuse history
  20. Patients who have severe neurologic and psychiatric disorders that affect clinical trials
  21. Patients who had participated in other clinical trials within 12 weeks prior to this study
  22. Patients who the principal investigator considers inappropriate for the clinical trial due to any other reasons than those listed above
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: SEOGJU LEE 82-2-6978-9226 tin50@stemcellbio.com
Contact: YUNHEE BAE yunheebae@kcrnresearch.com
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03990805
Other Study ID Numbers  ICMJE BSR-CTph3-JS1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party R-Bio
Study Sponsor  ICMJE R-Bio
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: KANGIL KIM KyungHee University Gangdong Hospital
Principal Investigator: WOOSUK LEE Gangnam Severance Hospital
Principal Investigator: SUNCHUL HWANG Gyeongsang National University Hospital
Principal Investigator: SANGJUN SONG Kyunghee University Medical Center
Principal Investigator: KICHEOR BAE Keimyung University Dongsan Medical Center
Principal Investigator: YOUNGWAN MOON Samsung Medical Center
Principal Investigator: JUHONG LEE Chonbuk National University Hospital
Principal Investigator: HANJUN LEE Chunang University Hospital
Principal Investigator: EUISUNG CHOI Chungbuk National University Hospital
Principal Investigator: HYUNGSUK CHOI Soonchunhyang University Hospital Seoul
Principal Investigator: KWANKYU PARK Yonsei University
Principal Investigator: OOGJIN SHON Yeungnam University Hospital
PRS Account R-Bio
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP